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Unapproved drugs, by prescription

Helen Palmer Jun 9, 2006

CHERYL GLASER: It may come as a surprise to you. It certainly did to us. There are hundreds and hundreds of unapproved prescription drugs out on the market. And thousands–if not millions–of people are buying and using them. Some of these medications pose a health threat. So now the Food and Drug Administration is cracking down on unapproved prescription drugs. From the Marketplace health desk at WGBH, Helen Palmer fills us in:

HELEN PALMER: Drug appproval was a haphazard affair before the FDA was set up in 1938. And there was no requirement that approved drugs did any good till Congress amended the rules in 1962. The FDA reviewed about 90% of drugs then in use.

KEN KAITIN: That still leaves about 10% of products that are still out there, many of them in common usage that were never studied to determine whether they have efficacy to support their use.

Ken Kaitin directs the Tufts Center for the Study of Drug Development. He says these are essentially illegal drugs, though they include many old, established therapies.

KAITIN: In a best case scenario they’re not doing any damage, but they’re not doing any good, in a worst case scenario they can do damage.

Kaitin says it’s great that the FDA’s taking action here — that’s its job — to keep us safe. But there’s another point of view — that of Perry Cole. He speaks for specialist drug makers as president of the Branded Pharmaceutical Association.

PERRY COLE: The FDA doesn’t want to be known as allowing unapproved products to be on the market. Unfortunately it gives products that have been considered safe and effective a bad name.

Cole says these old established drugs don’t earn a lot. The FDA wants his members to file New Drug Applications, but the companies say they don’t have the resources to produce all the data that it needs.

COLE: When it comes down to it, the FDA’s not concerned with what it costs the company.

Cole says unless the FDA can come up with some way of grandfathering these drugs in, some of his members may just have to abandon them. And that, he says, will be bad news for consumers who rely on them.

In Boston, I’m Helen Palmer for Marketplace.

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